In response to the AsthmaNet RFA, we have established the Atlantic Coast Consortium for Asthma (ACC-A) to serve as a clinical site. It consists of Wake Forest University Health Sciences (SP Peters, PI, Lead Investigator, Adults), University of Virginia (WG Teague, Co-PI, Lead Investigator, Children), Emory University (A Fitzpatrick, Co-I, Site Director), and North Carolina Clinical Research (C LaForce, Co-I, Medical Director). The group of investigators assembled has extensive experience as participants and lead investigators in national asthma networks including the Asthma Clinical Research Network (ACRN) 1 and 2, the Severe Asthma Research Program (SARP), the American Lung Association's Asthma Clinical Research Centers (ALA-ACRC), The Epidemiology and Natural History of Asthma: Outcomes and Treatment Regimens (TENOR) program, and SNP Typing for Association with Multiple Phenotypes from Existing Epidemiologic Data (STAMPEED, Genome wide Association for Asthma and Lung Function), and with a wide variety of asthma clinical trials. With this experience and extensive resources, we agree to participate in all aspects of AsthmaNet and propose two major protocols (with companion exploratory and mechanistic protocols) focusing on specific sub-sets of severe asthmatics in adults and children. Gene-Based Anti-TNF Therapy in Severe Asthma (Gene BATTS) is a randomized, double-blind, placebo-controlled genotype-stratified trial in adults designed to test the hypothesis that severe asthmatics with specific genetic variants in tumor necrosis factor (TNF) receptor genes respond better to anti-TNF than patients without these variants. Management Options for Severe Asthma in Children (MOSAIC) is a randomized, double-blinded, parallel group trial designed to determine the efficacy of 3 treatment regimes: 880 meg/day fluticasone alone, 440 meg/day fluticasone + BID salmeterol, and 440 meg/day fluticasone + BID ipratropium bromide in severe asthmatic children inadequately controlled on fluticasone 440 meg/day. Companion protocols will examine corticosteroid resistance (RASS) and a possible genetic mechanism for resistance (IMMOST) in adults, and the efficacy of inhaled S-nitrosoglutathione (N30-201) (SNORT) in children.
The Atlantic Coast Consortium for Asthma (ACC-A) and AsthmaNet have been established to perform clinical trials in adults and children with asthma, in order to define better treatment options for them. Through genetic, phenotypic (i.e. clinical), and other means, we hope to be able to identify the right asthma treatment forthe right patient, which both maximizes clinical benefit, and minimizes potential harm.
| Sorkness, Christine A; King, Tonya S; Dyer, Anne-Marie et al. (2018) Adapting clinical trial design to maintain meaningful outcomes during a multicenter asthma trial in the precision medicine era. Contemp Clin Trials 77:98-103 |
| Cardet, Juan Carlos; Louisias, Margee; King, Tonya S et al. (2018) Income is an independent risk factor for worse asthma outcomes. J Allergy Clin Immunol 141:754-760.e3 |
| Morris, Claudia R; Mauger, David T; Suh, Jung H et al. (2018) Glutathione and arginine levels: Predictors for acetaminophen-associated asthma exacerbation? J Allergy Clin Immunol 142:308-311.e9 |
| Durack, Juliana; Huang, Yvonne J; Nariya, Snehal et al. (2018) Bacterial biogeography of adult airways in atopic asthma. Microbiome 6:104 |
| Jackson, Daniel J; Bacharier, Leonard B; Mauger, David T et al. (2018) Quintupling Inhaled Glucocorticoids to Prevent Childhood Asthma Exacerbations. N Engl J Med 378:891-901 |
| Durack, Juliana; Lynch, Susan V; Nariya, Snehal et al. (2017) Features of the bronchial bacterial microbiome associated with atopy, asthma, and responsiveness to inhaled corticosteroid treatment. J Allergy Clin Immunol 140:63-75 |
| Nyenhuis, Sharmilee M; Krishnan, Jerry A; Berry, Alalia et al. (2017) Race is associated with differences in airway inflammation in patients with asthma. J Allergy Clin Immunol 140:257-265.e11 |
| Sheehan, William J; Mauger, David T; Paul, Ian M et al. (2016) Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma. N Engl J Med 375:619-30 |
| Fitzpatrick, Anne M; Jackson, Daniel J; Mauger, David T et al. (2016) Individualized therapy for persistent asthma in young children. J Allergy Clin Immunol 138:1608-1618.e12 |
| Fitzpatrick, Anne M (2016) Severe Asthma in Children: Lessons Learned and Future Directions. J Allergy Clin Immunol Pract 4:11-9; quiz 20-1 |
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